Standard Operating Procedure for Validating Sachet Filling for Granules
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized approach for validating the sachet filling process for granules in pharmaceutical manufacturing. This SOP ensures that the sachet filling process consistently meets product specifications, including correct fill weight, seal integrity, and labeling accuracy. By validating critical process parameters such as granule filling accuracy, seal quality, and packaging efficiency, this SOP guarantees that the final product is safe, effective, and compliant with regulatory standards.
2) Scope
This SOP applies to the validation of sachet filling operations for granules in pharmaceutical manufacturing. It covers the entire process, from granule formulation preparation to sachet filling, sealing, labeling, and final inspection. The SOP ensures that the process is validated for both manual and automated sachet filling systems. This SOP is applicable to new products and those undergoing significant changes in formulation, packaging equipment, or production methods.
3) Responsibilities
Operators: Responsible for operating the sachet filling equipment according to the validated protocol and ensuring that all critical process parameters are followed and documented.
Quality Assurance (QA): Ensures that the sachet filling process is validated in compliance with
Production Supervisors: Oversee the sachet filling process, ensuring that operators follow all required procedures and that the process is conducted according to the approved protocol.
Validation Team: Responsible for developing the sachet filling process validation protocol, executing the validation runs, and analyzing the results to ensure compliance with product and regulatory requirements.
Maintenance Personnel: Ensures that all sachet filling equipment, including granule feeders, filling machines, sealing machines, and labeling systems, are calibrated and maintained during the validation process.
4) Procedure
The following steps should be followed for the validation of sachet filling for granules:
1. Preparation for Validation:
1.1 Review batch records, product specifications, and regulatory guidelines to identify critical process parameters (CPPs) for the sachet filling process, such as fill weight, sealing integrity, and labeling accuracy.
1.2 Develop a process validation protocol that includes the objectives, scope, equipment, process flow, and personnel involved in the validation process.
1.3 Ensure that all equipment, including granule feeders, sachet filling machines, sealing machines, and labeling systems, are calibrated and operational before initiating the validation process.
1.4 Prepare granules and sachet packaging materials, ensuring that they meet the product specifications and are free from contamination.
2. Validation Protocol:
2.1 Protocol Design: The validation protocol should be based on the specific sachet filling equipment used and the granule formulation. The protocol should outline the steps to verify fill weight, seal integrity, and labeling accuracy.
2.2 Defining Acceptance Criteria: Establish acceptance criteria for critical parameters such as fill weight, seal integrity, label placement, and packaging speed. Define the acceptable limits for deviations in fill weight, sealing defects, and labeling errors.
2.3 Risk Assessment: Perform a risk assessment to identify critical quality attributes (CQAs) and corresponding critical process parameters (CPPs). This helps minimize the risk of packaging defects such as underfills, mislabels, or seal failures during the validation process.
3. Execution of Validation:
3.1 Filling Equipment Setup: Set up the sachet filling equipment according to the specified parameters, ensuring that the correct granule formulation, fill weight, and sealing settings are used.
3.2 Filling Process Execution: Begin the filling process, monitoring the fill weight for each sachet to ensure that it meets the established limits. Record fill weight data for each batch, and perform statistical sampling to confirm consistency.
3.3 Seal Integrity Testing: Perform seal integrity testing on a sample of filled and sealed sachets. Methods such as vacuum leak testing or dye penetration tests can be used to ensure that the seals are properly formed and that no leaks are present.
3.4 Labeling Inspection: Perform a visual inspection of the labeling process to ensure that the labels are correctly applied to each sachet. Verify that the labels contain accurate information, such as batch numbers, expiry dates, and dosage instructions.
3.5 Packaging Speed Monitoring: Monitor the packaging speed during the process to ensure that it remains within the defined limits and does not affect packaging quality. Record production rates and verify that throughput is within acceptable limits.
3.6 Final Packaging Inspection: Inspect the final packaged sachets to check for defects such as incorrect labeling, improper sealing, or damaged sachets. Perform tests on a sample of sachets to ensure packaging integrity is maintained throughout the batch.
4. Documentation and Reporting:
4.1 Record all data during the validation process, including batch records, equipment logs, process parameters, and test results for fill weight, seal integrity, labeling accuracy, and packaging speed.
4.2 Ensure that all forms, reports, and certificates are completed and signed by the responsible personnel.
4.3 Perform statistical analysis of the collected data to assess the consistency and capability of the sachet filling process. This analysis should confirm that the process consistently produces products that meet the acceptance criteria.
4.4 Prepare a final validation report summarizing the results of the validation, including any deviations, corrective actions, and conclusions regarding the sachet filling process.
5. Revalidation:
5.1 Revalidate the sachet filling process if there are significant changes to the formulation, equipment, or critical process parameters.
5.2 Periodically conduct revalidation to ensure continued compliance with regulatory requirements and confirm that the process consistently produces high-quality products.
5) Abbreviations
- QA: Quality Assurance
- CPP: Critical Process Parameter
- CQA: Critical Quality Attribute
- SOP: Standard Operating Procedure
- HPLC: High Performance Liquid Chromatography
6) Documents
- Process Validation Protocol
- Batch Production Records
- Equipment Calibration Logs
- Sachet Filling Process Validation Reports
- Fill Weight and Seal Integrity Test Records
- Labeling Inspection Records
- Packaging Speed Monitoring Logs
7) Reference
- FDA Guidance for Industry: Process Validation
- International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ISO 9001: Quality Management Systems – Requirements
- USP Chapter 1151: Pharmaceutical Dosage Forms
8) SOP Version
Version 1.0 – Effective Date: DD/MM/YYYY
Annexure
Template 1: Sachet Filling Process Record
| Date | Time | Operator Initials | Fill Weight (g) | Seal Integrity Test Result | Packaging Speed (units/min) |
|---|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | Weight in g | Pass/Fail | Speed in units/min |
Template 2: Labeling Inspection Record
| Batch No. | Inspection Date | Labeling Accuracy | Pass/Fail | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Pass/Fail | Pass/Fail | Operator Name |
Template 3: Packaging Speed Monitoring Record
| Batch No. | Test Date | Speed (units/min) | Production Time (minutes) | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Speed in units/min | Production time in minutes | Operator Name |